Systems and methods for thermal therapy

ABSTRACT

The present invention is directed to systems and methods for thermal therapy, especially to detection-guided, -controlled, and temperature-modulated interstitial thermal therapy. Thermal therapy may be used to treat the tissues of a patient. In the case of interstitial thermal therapy, energy is applied to generate heating of the tissue to affect treatment, such as, for example, thermally inducing tissue damage (e.g. thermally-induced tissue necrosis), which may be useful in treating tumors and/or other diseased tissues. Since targets for thermal therapy are internal to the patient, the use of detection guidance may be useful in locating and monitoring treatment of a target tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/418,562 filed on Apr. 3, 2009, now U.S. Pat. No. 9,403,029 issued onAug. 2, 2016, which: (1.) is a continuation-in-part of U.S. patentapplication Ser. No. 12/176,310 filed on Jul. 18, 2008, now abandoned,which claims benefit of U.S. Provisional Patent Application No.60/950,536 filed on Jul. 18, 2007; and (2.) claims benefit of U.S.Provisional Patent Application No. 61/042,199 filed on Apr. 3, 2008. Theentire disclosures of each of the above applications are incorporatedherein by reference.

FIELD

The present invention relates to systems and methods for thermaltherapy, especially to detection-guided, -controlled, andtemperature-modulated interstitial thermal therapy.

BACKGROUND

In the medical industry, undesirable lesions can be treated throughtheir removal. It is known to have a practitioner, such as a doctor,physically remove such lesions through surgery. It is also known to havea practitioner destroy lesions by controlling an application of heatlocal to the lesion. Known processes whereby a practitioner destroys thelesion by using heat require the practitioner to control the processbased on visual data and temperature data. Based upon this information,the practitioner will modify the heat source to change an attribute ofthe heat, such as its location, direction, and intensity. The properapplication of the heat delivery process is dependent upon the abilityof the practitioner to interpret available visual and temperature data,and to implement an appropriate treatment in response. As a result, theability to control processes in a predictable manner varies betweenpractitioners, and even varies instance-to-instance for a givenpractitioner.

SUMMARY

The present invention is directed to systems and methods for thermaltherapy, for example, to detection-guided, -controlled, and/ortemperature-modulated interstitial thermal therapy. Thermal therapy maybe used to treat the tissues of a patient by transferring energy, suchas applying energy and/or removing energy. In the case of interstitialthermal therapy, energy is applied to generate a temperature change inthe tissue to affect treatment, such as, for example, thermally inducingtissue damage (e.g. thermally-induced tissue necrosis), which may beuseful in treating tumors and/or other diseased tissues. Since targetsfor thermal therapy are internal to the patient, the use of image and/ora form of detection guidance may be useful and/or desirable in locatingand monitoring treatment of a target tissue.

In one aspect of the present invention, a thermal therapy systemincludes at least one detection device, at least one treatment deviceand at least one control system. In one embodiment, a treatment devicemay be inserted into and/or in the vicinity of the body of a patient andmonitored by the detection device for proper placement near a targettissue. A treatment device may generally be an energy delivery devicesuch as, for example, a laser probe, a radio frequency (RF) probe, amicrowave device, an electromagnetic antenna, an ultrasound probe, abrachytherapy device, and/or any other appropriate energy deliverydevice. Treatment devices may also include, but are not limited to,biopsy and/or material removal devices, material introducing devicessuch as catheters and/or injection devices, target access devices,and/or any other appropriate device. In general, an energy deliverydevice may be selected for compatibility with a given detection deviceand/or for a particular type of treatment. A detection device mayemploy, but is not limited to, a magnetic resonance imaging (MRI),ultrasound imaging, X-ray or other electromagnetic imaging, positronemission tomography (PET) imaging, and/or any other appropriate imagingand/or detection modality. In general, an imaging and/or detectionmodality capable of detecting and/or mapping temperature responsesand/or thermally- and/or energy-induced changes to tissues may beutilized.

The treatment device may be an energy delivery device in communicationwith a control system which may also receive information from adetection device. The control system may generally incorporate apredictive and/or adaptive treatment modulation in a feedback responsemanner with the detection device and treatment device if desired. In anexemplary aspect, the control system, for example, may control at leastone treatment device to transfer, for example, a predetermined amount ofenergy between the treatment device and at least a portion of a target.In an exemplary embodiment, the control system utilizes informationabout the target from the detection device, which may, for example,contain temperature-sensitive information and/or spatially-resolvedinformation about at least a portion of the target. The control systemand/or a user may then determine a preselected amount of energy totransfer between a treatment device and at least a portion of the targetbased at least in part on the information from the detection device. Theenergy may then be transferred by at least one treatment device and theeffect on the target may then be determined by a detection device. Thecontrol system may further store information on previous energytransfers, such as over the general course of a therapy and/ortreatment, and may generally base an amount of energy to be transferredat least in part on previous energy transfer information. Previousinformation may be stored by the control system in, for example, amemory module and/or other information storage device and/or system. Insome embodiments, multiple energy transfers may be utilized.

In general, a thermal therapy system may be utilized to deliver energyto a target tissue such that the tissue may form a lesion bythermally-induced necrosis. This may be useful and/or desirable intreating harmful tissue formations such as, for example, tumors.

In an exemplary embodiment, the treatment device is a laser with a fluidcirculation probe. In general, the probe may include an optical fiberand/or other light transporting medium, and may also include a diffusingand/or targeting element for placement of the energy delivered throughthe light transporting medium from the laser. The fluid circulation inthe probe may be used to affect the temperature of the probe and/or thetissue surrounding the probe by circulating fluid of a desiredtemperature. The temperature of the fluid may be varied to determine thetemperature effect on the probe and/or tissue. The flow characteristicsof the fluid and energy output of the laser may be determined by thecontrol system such that it may modulate the energy deliverycharacteristics of the laser to the tissue.

The control system may receive temperature and/or spatial informationfrom a detection device that may detect features and/or changes to thetissues of a patient. The control system may then utilize theinformation to monitor the progress of a treatment, if desired. In anexemplary embodiment, the treatment device may be a laser. In oneembodiment, the device may be a laser with a fluid circulation probe. Ingeneral, the probe may include an optical fiber and/or other lighttransporting medium, and may also include a diffusing and/or targetingelement for placement of the energy delivered through the lighttransporting medium from the laser. The fluid circulation in the probemay be used to affect the temperature of the probe and/or the tissuesurrounding the probe by circulating fluid of a desired temperature. Thetemperature of the fluid may be varied to determine the temperatureeffect on the probe and/or tissue. The flow characteristics of the fluidand energy output of the laser may be determined by the control systemsuch that it may modulate the energy delivery characteristics of thelaser to the tissue.

In some embodiments, the circulating fluid may be utilized to cool theprobe and the surrounding tissue. This may be useful in protecting theprobe from thermal damage and may also be utilized to help minimizecarbonized tissue formation around the probe during treatment, such thatthe energy being delivered may reach further from the probe.

In other embodiments, the circulating fluid may also be utilized toraise the temperature of the tissue surrounding the probe before and/orduring treatment such that, for example, the tissue may reach a giventemperature faster during energy delivery by the probe. The temperaturemay also be raised if the control system determines that insufficientheating is occurring in the tissue to affect treatment, if desired.Raising the temperature of the tissue may also generally enhance thesize of the ablated volume as a smaller increase in temperature may berequired by energy delivery from the treatment device, particularly atdistances further away from the treatment device.

The fluid may be circulated at a constant rate or it may be circulatedat a variable rate, which may include periods of no circulation, duringthe course of a treatment. The temperature of the fluid may also bevaried during the course of a treatment.

In some embodiments, the temperature in the locality of the tissue fortreatment may be altered by altering the temperature of the circulatoryflow and/or surrounding tissue. This may be accomplished through avariety of methods, which may include, but are not limited to,introducing temperature controlled fluid into the circulatory flow, suchas through a nearby blood vessel; altering the temperature of thecirculatory flow by contact with a closed temperature controlled object,such as a closed catheter which may contain circulating temperaturecontrolled fluid; contacting the nearby tissue with a temperaturecontrolled object or material, such as a hot or cold pad; and/or anyother appropriate method. For example, a temperature controlled energydelivery device and/or heating element may be placed in a blood vesselwhich may be in proximity to and/or supply a tissue for treatment.

In still other embodiments, the thermal therapy system may incorporatemultiple treatment devices, which may be the same or different. Thetreatment devices may be controlled as a group or they may beindividually controlled. The treatment devices may be spatially orientedin or near a tissue for treatment and may be utilized to affecttreatment in a spatially controlled manner. The treatment devices may,for example, be targeted in particular directions for coverage of atreatment area. The treatment devices may also be controlled in atemporal manner by controlling the activation and/or modulation of eachdevice in a time-dependent manner.

In an exemplary embodiment, the multiple treatment devices may be laserprobes with fluid circulation, as discussed above, and may beindividually modulated by the control system. The laser probes may, forexample, be spatially oriented in or near a tissue for treatment tooptimize and/or increase the volume being treated. This may be used, forexample, to increase the overall size of a thermally generated lesion.Each laser probe may also be targeted such that energy delivery may besubstantially confined to a given volume. The fluid circulationcharacteristics of each laser probe may also be individually modulated,as discussed above.

The control system of the thermal therapy system may incorporatepredictive and/or adaptive treatment modulation, as noted above. In oneembodiment, the control system may generate a predictive model of atreatment based on known and/or assumed parameters, and may calculate anappropriate treatment course, such as, for example, applying energy to atissue at a particular rate and/or duration based on the predictedmodel. The control system may then monitor the progress of treatment byreceiving information from a detection device, and/or it may then adaptto the measured progress of the treatment by entering and/or alteringparameters in the predicted model to aid in generating a more accuratemodel, after which the control system may apply a modulation to thetreatment, such as, for example, an alteration to the energy deliverycharacteristics of a treatment device.

The thermal therapy system may incorporate safety systems. In oneembodiment, the control system of a thermal therapy system may shut downthe treatment device and/or warn the user of a detected safetyparameter. The control system may, for example, shut down the treatmentdevice in response to a detected temperature above a given level in theinformation provided by a detection device. This may be useful indetecting failures in a treatment device, such as, for example, a laserlight transport medium breaking and/or otherwise overheating past adesign limitation. This may also be useful by halting treatment if thetemperature of the tissue being treated and/or nearby tissue exceeds agiven safety threshold.

Communication between devices as used herein may include physicalcontact, physical connection, wired or wireless connection, or integralwith each other.

The present invention together with the above and other advantages maybest be understood from the following detailed description of theembodiments of the invention illustrated in the drawings

DRAWINGS

FIG. 1 illustrates a thermal therapy system in one embodiment of thepresent invention;

FIG. 1a illustrates another embodiment of a thermal therapy system;

FIG. 1b illustrates a temperature profile utilizing from stepped energytransfers;

FIG. 2 illustrates an embodiment of a treatment device;

FIGS. 2a and 2b illustrate the use of a scattering material with atreatment device;

FIGS. 2c, 2d and 2e illustrate embodiments of treatment devices withenergy directing components;

FIG. 2f illustrates a coupling assembly of a treatment device;

FIGS. 3, 3 a and 3 f illustrate the use of multiple treatment devices;

FIGS. 3b and 3e illustrate embodiments of multiple treatment deviceguides;

FIGS. 3c and 3d illustrate embodiments of fiducial markers; and

FIG. 4 is a flow diagram of a method of use for a thermal therapysystem.

DETAILED DESCRIPTION

The detailed description set forth below is intended as a description ofthe presently exemplified systems, devices and methods provided inaccordance with aspects of the present invention, and is not intended torepresent the only forms in which the present invention may be practicedor utilized. It is to be understood, however, that the same orequivalent functions and components may be accomplished by differentembodiments that are also intended to be encompassed within the spiritand scope of the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which this invention belongs. Although any systems, methods,devices and materials similar or equivalent to those described hereincan be used in the practice or testing of the invention, the exemplifiedmethods, systems, devices and materials are now described.

The present invention is directed to systems and methods for thermaltherapy that may be used to treat the tissues of a patient by applyingenergy and/or removing energy. In the case of interstitial thermaltherapy, energy is applied to generate a temperature change of thetissue to affect treatment, such as, for example, thermally inducingtissue damage (e.g. thermally-induced tissue necrosis), which may beuseful in treating tumors and/or other diseased tissues. Since targetsfor thermal therapy are internal to the patient, the use of image and/ora form of detection guidance may be useful in locating and/or monitoringtreatment of a target tissue.

In general, thermal therapy may be defined as a treatment that altersthe temperatures or temperature profile of a target, more for example,to the application and/or removal of energy from a target to affect atemperature change or temperature profile change. This may generallyinclude heating, cooling and/or dynamic combinations thereof. Thermaltherapy may generally be accomplished through the energy deliverycharacteristics of a treatment device or devices. Energy deliverycharacteristics may generally refer to the rate of energy applicationand/or removal from a target, and the factors contributing to the rate.Energy delivery devices may in general refer to devices for alteringand/or maintaining the temperature of a target, such as devices thatapply energy to a target and/or devices that remove energy from atarget. It may also be appreciated that devices useful for applyingand/or delivering energy may be useful for removal of energy. Inaddition, for example, the same device may be useful for simultaneousapplying and removal of energy. Also, transferring of energy refers toapplying and/or delivering energy and may also refer to removal ofenergy.

One example of thermal therapy is laser interstitial thermal therapy(LITT). LITT employs a laser energy source which transmits light througha light transmitting medium such as a fiber optic to a probe at a targettissue. The probe may target the delivery of energy from the laser tothe tissue through a variety of methods, which may include, for example,focusing, diffusing/scattering, reflecting and/or otherwise directingthe light from the laser. LITT is generally performed using opticalradiation in the near-infrared wavelength range, from, for example,about 700-2000 nm, though when appropriate chromophores are available,visible wavelengths may also be used. When light is absorbed by thetissue, the energy from the photons may be converted into inter- andintra-molecular energy and results in generation of heat within thetissue. At temperatures of 100 degrees Celsius or more, water in thetissue and in the intracellular compartments may vaporize and lead torupture or explosion of cells or tissue components. At temperaturesabove 60 degrees Celsius, proteins and cellular components of the tissuebecome severely denatured and coagulate leading to cell and tissuedeath. At somewhat lower temperatures, generally above 45 degreesCelsius, prolonged exposure leads to the thermal denaturation ofnon-stabilized proteins such as enzymes. Though cell death may not beimmediate, destruction of critical enzymes may lead eventually to celldeath.

In one aspect of the present invention, as shown in FIG. 1, a thermaltherapy system 100 includes at least one detection device 110, treatmentdevice 120 and control system 130. In one embodiment, a treatment device120 may be inserted into and/or in the vicinity of the body 80 of apatient and monitored by the detection device 110 for proper placementnear a target tissue. A treatment device 120 may generally be an energydelivery device such as, for example, a laser probe, a radio frequency(RF) probe, a microwave device, an electromagnetic antenna, anultrasound probe and/or any other appropriate energy delivery device. Ingeneral, a treatment device 120 may be selected for compatibility with agiven detection device 110 and/or for a particular type of treatment. Adetection device 110 may employ, but is not limited to, a magneticresonance imaging (MRI), ultrasound imaging, X-ray or otherelectromagnetic imaging, positron emission tomography (PET) imaging,and/or any other appropriate detection modality. In general, a detectionmodality capable of detecting and mapping temperature changes and/orthermally-induced changes to tissues, and/or providing localizedtemperature information may be utilized. A detection device 110 oraccessory detection device may also be utilized to measure absolutetemperature rather than a relative temperature change.

The treatment device 120 may be an energy delivery device incommunication with a control system 130 which may also receiveinformation from a detection device 110. The control system 130 maygenerally act in a feedback response and/or sequential detection mannerwith the detection device 110 and treatment device 120, if desired, asshown in FIG. 1. The control system 130 may receive information from adetection device 110 that may detect features and changes to the tissuesof a patient 80. The control system 130 may then utilize the informationto program a treatment and/or monitor the progress of a treatment. Forexample, the control system 130 may recognize changes in temperatureand/or tissue characteristics in the information. The control system 130may then modulate the energy delivery characteristics of the treatmentdevice 120 such that the treatment is controlled. The control system 130may also control the detection device 110, such as, for example, foraltering the detection settings, altering the detection space or area,changing the detection rate, such as an image capture rate, and/or anyother parameter or available setting on the detection device 110.

FIG. 1a illustrates a thermal therapy system in accordance with oneembodiment of the present invention having one or more detectiondevices, one or more data processors, and one or more energy deliverydevices, and a control system, as well as a method for its use. Thethermal therapy system may utilize a detection device to periodically orcontinuously measure the temperature and/or cell damage of a targetreceiving energy. In at least one embodiment, a user may input desiredparameters to define a control strategy for the energy delivery. Thedata processor may use the control strategy to govern the behavior ofthe energy delivery devices in real time, or near real time, usingdetection information from the detection device. The data processor mayalso be capable of displaying images representative of temperature,damage, and/or structure to the user, as well as inputting user-definedparameters, with a graphical user interface (GUI).

A feedback-controlled energy delivery system 200 is illustratedaccording to one embodiment of the present invention. Energy deliverysystem 100 includes detection device 110, energy delivery device 120 andcontrol system 130. The control system 130 may include data processor132. The detection device 110 may use radiation to interrogate a targetor other suitable system capable of acquiring temperature and/or otherinformation from a target 90. In one embodiment, target 90 may includebiological tissue to be destroyed by heating, and/or any other objecthaving specific localized areas to be heated without damagingsurrounding areas. Detection device 110 may include a magnetic resonancedevice, an ultrasound device, an infrared device, a radio frequencydevice, x-ray device, infrared detection device, computerized tomography(CT) device, and/or any other appropriate detection modality.

Data processor 132 may include any data processing system capable ofreceiving and processing data from detection device 110 to control, on areal-time or near real-time basis, the energy delivery device 120. Dataprocessor 132 may include a workstation, personal computer,supercomputer, dedicated hardware, computing cluster and/or any otherappropriate device or combination thereof. Energy delivery device 120may include any device capable of generating heat, or energy that may betransformed to heat, and further capable of conveying this heat orenergy to target 90 via one or more applicators, such as in theembodiments described below. Energy delivery device 120 may include alaser device, a microwave device, a resistive heater, radio frequencydevice, an ultrasound device, a heated fluid device, a radiation sourcesuch as an ion beam source and/or any other appropriate device. It maybe appreciated that data processor 132 may be either locally or remotelyconnected to detection device 110 and energy delivery device 120.

In one embodiment of the present invention, detection device 110 mayobtain temperature sensitive data 111 on a periodic or continuing basis.The detection device 110 may, for example, transmit temperaturesensitive data 111 to the control system 130. The temperature sensitivedata 111 may represent the absolute or relative temperature distributionof a point, area plane, contour, or volume of a portion of target 90.For example, a magnetic resonance device may be used to capture data tobe processed for determining the structure of selected portions oftarget 90, as well as the selected portions' relative temperaturedistribution at a given point in time. After detection device 110captures data 111 from target 90 for one cycle, data 111 may be eitherstored in a database in detection device 110 and transmitted at a latertime to data processor 132, or the captured data 111 may be immediatelysent to data processor 132. It may be appreciated that detection device110 may pre-process data 111 before it may be transmitted to dataprocessor 132. The detection device 110 and/or the data processor 132may also include features for motion correction, such as, for example,to compensate for unintended movement of the target 90 within thedetection space. The data processor 132 may, for example, also outputmotion correction information and/or instructions to the detectiondevice 110 for any detected movement of the target 90 such that thedetection device 110 may alter or re-orient the detection space and/orotherwise compensate for the movement.

In some embodiments, the control system 130 may actively acquire and/ordetect updated data 111 produced by the detection device 110. This maybe, for example, desirable with some detection devices, such as MRIscanners, that operate by saving data into a designated file systemdirectory or the like. In one embodiment, a method of obtaining data 111from real-time and/or near-real-time detection device 110 may includeestablishing a direct and/or network connection between the detectiondevice 110 and the control system 130, examining the contents of atarget file-system directory, and transferring new files appearing inthat directory as they become available and/or in a short timethereafter. A direct connection may include, for example, any form ofdirect electronic and/or wireless connection such as Universal SerialBus (USB), serial connection, IR connection, wireless fidelity (WIFI),radio connection, and/or any other appropriate connection. A networkconnection may also be utilized. For example, a file transfer protocol(FTP) connection, a server message block (SMB) protocol connection, anetwork file system (NFS) protocol connection, Internetwork PacketExchange/Sequenced Packet Exchange (IPX/SPX) network protocol, tokenring network protocol and/or any other appropriate network connectionmay be utilized.

In some embodiments, the method of acquiring data 111 from the detectiondevice 110 may further include searching for, calculating, computing,and/or determining a target directory on the file system of a detectiondevice 110. The method may also include searching for new files toarrive in that directory. The arrival of new files may be determined bycounting the number of files in the directory, comparing a listing ofthe files in the directory to a previous saved list of the files in thesame directory, searching by file update times, and/or any otherappropriate method of detecting new files.

The method of computing, calculating, or determining the directory namemay include sorting directory names based on time-stamps, sorting basedon numeric or alphabetical components of the directory name, orcalculating a numeric value which determines the directory name. Thedirectory may also be determined by examining the time stamps of all orsome directories and selecting the most recently created and/or mostrecently accessed. Specific examples of acquiring data 111 from adetection device 110 are discussed below.

In one embodiment of the present invention, data processor 132 mayreceive data 111 as input data from detection device 110 and processingdata 111 to control the operation of the energy delivery device 120and/or to display information to the user via a graphical user interface(GUI) 136. Some of the information displayed to the user using GUI 136may include images representative of the temperature of a portion oftarget 90, the structure of a portion of target 90, the dead and dyingcells in a portion of target 90 (where target 90 is biological tissue),and/or any other appropriate information. Other information displayedmay include the status of energy delivery device 120, the temperaturehistory of one or more points, areas, contours, planes, or volumes of aportion of target 90, etc. In one embodiment, data processor 132 mayalso accept user-defined parameters input 134 through GUI 136.

Irreversibly damaged tissue may be displayed using an imagerepresentative of damage in GUI 136. A portion of tissue may beconsidered irreversibly damaged when the cells of the tissue portion aredead, or damaged enough, through protein denaturization, watervaporization, etc., that it is determined, using empirical data,previous experience, or models, that the cells may likely die within arelatively short time span. In one embodiment, a image representative ofdamage may be constructed using the temperature history for a givenportion of tissue. One method of determining tissue damage may utilizetemperature history to determine a total amount of heat absorbed bytissue in an area. This may be achieved by keeping a summation of alltemperatures measured for a given portion of tissue. If the sum total ofheat for the given portion exceeds a predetermined value, the cells inthat portion may be considered dead or dying. In one embodiment, theArrhenius rate equation may be used to calculate irreversible celldamage as a function of the temperature history. The Arrhenius rateequations is commonly expressed as follows: Ω=.intg.A*e-Ea/(RT) dtWherein:

A is the frequency factor constant for a given tissue type;

Ea is the activation energy value specific to the type of tissue;

R is the Universal Gas Constant; and

T is the temperature history of the tissue as a function of time; and acell is considered dead or dying if the value of Ω is greater than orequal to one when the equation is evaluated.

The Arrhenius rate equation may be integrated with respect to time for agiven location of tissue, and if the integrated value is greater than adetermined value, then the cells in the location may be consideredirreversibly damaged. It may be appreciated that the determined value,based on tissue type, may be a result of empirical analysis, a user'sexperience, models, or theory. As it may be rare and/or difficult tohave a defined, continuous equation for cell temperature as a functionof time, the Arrhenius rate equation may be evaluated numerically byusing linear and/or non-linear interpolation between temperature historypoints. It may be appreciated that as the time difference betweentemperature history points decreases, the degree to which linear and/ornon-linear interpolation emulates the real temperature history of agiven location of tissue may increase.

Damage distribution data, in addition to (or in place of) temperaturedata, may be used to determine the control of a treatment device 120.Since the damage to a cell in many cases may be dependent on theproperties of the cell type, location, and the like, the appropriatevalues for constants of the Arrhenius equation may be determined, forexample, for a given target. The user may use previous experience,tables, or may load the values from a database or a file. Alternately,the values may be hardcoded into software used by data processor 132,automatically uploaded from a database, and/or otherwise provided.Incorrectly determining the total heat needed may result in charring ofthe cells if the history of heat received is enough to char the cells orif an absolute maximum temperature is exceeded. Similarly, if not enoughheat is absorbed by the cells in tissue, or if a minimum temperatureneeded to cause cell death or irreversible damage is never reached, thecells may not be dead or dying, although they may be displayed as deador dying cells in an image representative of damage.

Further exemplary embodiments of a control system, detection device andtreatment device relationship may be found in U.S. Pat. No. 6,542,767,the entire contents of which are hereby incorporated by reference.

In an exemplary aspect, the control system 130 controls at least onetreatment device 120 to transfer a predetermined amount of energybetween the treatment device 120 and at least a portion of a target. Inan exemplary embodiment, the control system 130 utilizes informationabout the target from the detection device 110, which may, for example,contain temperature-sensitive information and/or spatially-resolvedinformation about at least a portion of the target. The control system130 and/or a user may then determine a preselected amount of energy totransfer between a treatment device 120 and at least a portion of thetarget based at least in part on the information from the detectiondevice 110. The energy may then be transferred by at least one treatmentdevice 120 and the effect on the target may then be determined by adetection device 110. The control system 130 may further storeinformation on previous energy transfers, such as over the generalcourse of a therapy and/or treatment, and may generally base an amountof energy to be transferred at least in part on previous energy transferinformation. Previous information may be stored by the control system130 in, for example, a memory module and/or other information storagedevice and/or system. This may be desirable as a transfer of energy maygenerate a change in a target that may be unexpected. Utilizing previousenergy transfer information may then aid in correcting for unexpectedevents, properties and/or parameters of a therapy and/or treatment.

In some embodiments, the control system 130 may control at least onetreatment device 120 to generate multiple energy transfers between thetreatment device 120 and at least a portion of a target. Multiple energytransfers may be utilized, for example, to affect a temperature-inducedchange on at least a portion of a target. In one embodiment, the controlsystem 130 may control a series of stepped energy transfers to, forexample, substantially gradually change the temperature of at least aportion of a target. In general, it may be desirable to affect apredetermined temperature change in at least a portion of a target andsubstantially only to a particular portion of a target. In one example,it may be desirable to change the temperature of a portion of tissue toa predetermined level without substantially changing the temperature ofthe rest of the tissue to that level. This may, for example, aid inmitigating temperature-induced changes, such as damage, to portions of atissue outside a target area. Gradual temperature changes may then beutilized to, for example, aid in preventing exceeding a boundarytemperature value in at least a portion of a target.

In one embodiment, as illustrated in FIG. 1b , a control system 130 maycontrol multiple energy transfers over time 61 at times, for example, 61a, 61 b, 61 c, 61 d. The temperature 60 of at least a portion of atarget may, for example, be detected by detection device 110 astemperature profile 62. As described above, a stepped and/or otherwisegradual predetermined energy transfers and the effect may be detected attimes, for example, 61 a, 61 b, 61 c, 61 d. This may be utilized, forexample, to aid in preventing or minimizing temperature from exceeding agiven value, such as temperature 64. Such gradual and/or asymptoticapproaches to a given temperature value may generally be desirable toaid in minimizing or preventing exceeding a given value, especially whenthere may be a possibility of reaching the given value between detectionsteps.

In one exemplary embodiment, the energy delivery in stepwise fashion maybe delivered in gradually decreasing energy strength, also in minimizingexceeding a given value.

In general, a thermal therapy system 100 may be utilized to deliverenergy to a target tissue such that the tissue may form a lesion bythermally-induced necrosis. This may be useful in treating harmfultissue formations such as, for example, tumors.

In an exemplary embodiment, the treatment device 120 includes a laserwith a fluid circulation probe. In general, the probe may include anoptical fiber and/or other light transporting medium, and may alsoinclude a diffusing and/or targeting element for placement of the energydelivered through the light transporting medium from the laser. Thefluid circulation in the probe may be used to affect the temperature ofthe probe and/or the tissue surrounding the probe by circulating fluidof a desired temperature. The temperature of the fluid may be varied todetermine the temperature affect on the probe and/or tissue. The flowcharacteristics of the fluid and energy output of the laser may bedetermined by the control system 130 such that it may modulate theenergy delivery characteristics of the laser to the tissue.

FIG. 2 illustrates an embodiment of an exemplary energy delivery deviceof a treatment device 120. The treatment device 120 includes an energydelivery apparatus 1, an energy delivery component 2, an energy source4, and a circulation media supply apparatus 6. The proximal end of theenergy delivery component 2 is coupled to the output of the energysource 4. The distal end 3 of the energy delivery component 2 extendswithin the energy delivery apparatus 1. The circulation medium supplyapparatus 6 is connected to the inlet fluid port 8 of the energydelivery apparatus 1. The outlet fluid port 10 is either connected backto the circulation medium supply apparatus 6 (recirculating system) orto a suitable waste collection area (non-recirculating system). Theenergy source 4 and the circulation medium supply apparatus 6 may bemodulated by the control system 130 such that the energy deliverycharacteristics of the treatment device 120 may be controlled.

In an exemplary embodiment, the energy delivery apparatus 1 includes ahousing 12 attached to a coupling assembly 26. A dividing structure 16separates the lumen of housing 12 into two channels. A first channel 20is formed between the dividing structure 16 and the housing 12 and asecond channel 18 is formed between the energy delivery component 2 andthe dividing structure 16. The channels 18 and 20 communicate near orproximate the distal end of the housing 12 to allow fluid to pass fromone channel to the other in circulation chamber 3. The channels 18 and20 may be isolated proximate the coupling assembly 26 to allow fluid to,for example, enter port 8, flow through channel 18, return throughchannel 20, and exit via the outlet port 10. Also, in other embodiments,the fluid may flow in the opposite direction. In this manner, countercurrent circulation media flow cools the housing 12, the dividingstructure 16, the energy delivery component 2, and the surroundingtissue. In the above exemplary embodiment, the dividing structure 16 isdepicted as tubular and the channels 18 and 20 are depicted as annuli orconcentric flow paths. However, various shaped dividing structures 16 orshaped housings 12 may be used to form channels. As such, the tube-likestructures, 12 and 16, may have cross-sectional shapes such as stars,squares, triangles, ovals, circles, and other shapes. Multiple annuli orconcentric flow paths may also be utilized using multiple dividingstructures.

The coupling assembly 26, as illustrated in FIGS. 2 and 2 f, may includethe inlet fluid port 8, outlet fluid port 10 and an opening 30 forintroducing an energy delivery component 2. An example of a couplingassembly 26 may be formed by mating two male-female taper luer tees,such as part# LT878-9, Value Plastics, Inc. A male Touhy Borst connector32, such as part#80344 Qosina, may be included to provide asubstantially leak-proof seal at the energy delivery component opening30 and for securing the energy delivery component 2 to the couplingassembly 26. The distal segment 34 of the coupling assembly is bonded tothe outer housing 12 to create a fluid tight seal. A proximal section 36of coupling assembly 26 contains a seal 38 between the inner tubularstructure 16 and the proximal section 36 to prevent fluid communicationbetween inlet fluid port 8 and outlet fluid port 10 within the couplingassembly 26. Both distal and proximal seals and other bonds may becreated using a suitable UV cure epoxy, such as Part#140-M, Dymax Corp.Alternative methods of bonding and sealing may be used including variouscyanoacrylates, epoxies, silicones, heat bonds, press fits, and threadedassemblies, among other methods. Solvent bonding may also be used tomount the tubular structure 16 into the coupling assembly 26. Ingeneral, one or more solvents of the materials of the components may beutilized to partially dissolve the joining surface(s), which may thenjoin together as the solvents evaporate and/or otherwise dissipate. Itis contemplated that the opening 30 and one of inlet fluid port 8 oroutlet fluid port 10 may be coincident.

In one exemplary embodiment, the energy delivery apparatus 1 and theenergy delivery component 2 are integrated or assembled just prior toinsertion into the tissue. In another exemplary embodiment, the energydelivery apparatus 1 and the energy delivery component 2 are integratedor assembled during manufacture prior to being delivered for use.

The energy delivery apparatus 1 includes a flexible outer housing 12having a tubular structure along its length and a penetrating tip 14 atits distal end. The outer housing 12 may, for example, be rigid enoughto penetrate soft tissue without kinking, yet be flexible enough tofollow curved or arcuate paths. The solid penetrating tip 14 may takethe form of a cutting edge or a point, among others. The housing 12contains an inner tubular structure 16 within its lumen that extendsbetween a proximal end and a distal end of the outer housing 12. Theinner tubular structure 16 may be centered within the housing 12 tocreate fluid inlet lumen 18, and fluid outlet lumen 20. The inlet andoutlet lumens (18 and 20) facilitate delivery and return of circulationmedia (e.g. water, saline, or carbon dioxide, among others) to and fromthe distal end of the energy delivery apparatus 1. The fluid inlet lumen18 facilitates housing of the energy delivery component 2. Suitablematerials for the flexible outer housing 12, and inner tubular structure16 include flexible radio-opaque and non radio-opaque medical gradeplastic tubing, such as polycarbonate (Makrolon, Bayer Polymers),polyurethane, polyethylene, polypropylene, silicone, nylon,polyvinylchloride (PVC), polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS),polyether sulphone (PES), polyetheretherketone (PEEK), fluorinatedethylene propylene (FEP), other biocompatible polymers, or anycombination thereof.

The energy delivery component 2 disposed within the fluid inlet lumenmay include one or more optical waveguides positioned to direct lightthrough both the inner tubular structure 16 and outer housing 12. Insome embodiments, the energy delivery component 2 may be movablerelative to the energy delivery apparatus 1, for example, translatingalong the axis of the energy delivery apparatus 1. Energy emitted theenergy delivery component 2 may pass through transparent housing 12 andstructure 16. More than one region of tissue located along the housing12 may be treated by moving the energy delivery component 2. Furtherexamples of exemplary treatment devices are described in U.S. Pat. No.7,270,656, the entire contents of which are hereby incorporated byreference.

In some embodiments, the circulating fluid may be utilized to cool theprobe and the surrounding tissue. This may be useful in protecting theprobe from thermal damage and may also be utilized to help minimizecarbonized tissue formation around the probe during treatment, such thatthe energy being delivered may reach further from the probe.

In other embodiments, the circulating fluid may also be utilized toraise the temperature of the tissue surrounding the probe before and/orduring treatment such that, for example, the tissue may reach a giventemperature faster during energy delivery by the probe. The temperaturemay also be raised if the control system 130 determines thatinsufficient heating is occurring in the tissue to affect treatment.

The fluid may be circulated at a constant rate or it may be circulatedat a variable rate, which may include periods of no circulation, duringthe course of a treatment. The temperature of the fluid may also bevaried during the course of a treatment.

In some embodiments, the circulation media supply apparatus 6 maydeliver a fluid with light scattering properties. In one embodiment, thecirculation media may have a high refractive index such that light fromthe energy delivery component may be scattered at angles diverging fromthe generally longitudinal axis of the housing. In an exemplaryembodiment, the circulation media may include at least one scatteringmaterial 70, as shown in FIG. 2a , which may be held in solution orsuspension in the circulation media. The scattering material 70 may be,for example, a particulate material that may be dispersed within thecirculation media. The circulation media may then be utilized to scatterlight from the energy delivery component 2 in the circulation chamber 3and/or other portions of the energy delivery apparatus 1. In general,the physical properties of the scattering material 70 may be selected toprovide desired scattering characteristics. For example, the size of aparticle may be changed to yield a different degree of scattering. As afurther example, the solubility or the ability of a substance to stay insuspension may also be utilized to produce desired scatteringcharacteristics. Appropriate materials for a scattering material mayinclude, but are not limited to, plastics, metals such as gold,platinum, silver, aluminum and copper, glasses, metal oxides such astitanium dioxide, zinc oxide and alumina, silica or silicates and/or anyother appropriate scattering material or combination thereof. Thescattering material 70 may generally be provided in the circulationmedia at an appropriate concentration to effect scattering of light fromthe energy delivery component 2. The scattering material may come, forexample, premixed with the circulation media and may also be reusedduring a procedure. In an exemplary embodiment, a circulation mediasupply apparatus 6′ may include a scattering media reservoir 6 a′, afluid reservoir 6 b′ and a mixing unit 6 c′ which may mix the scatteringmaterial 70 with the circulation fluid, as shown in FIG. 2b . The mixingunit 6 c′ may also be controlled by the control system 130 such that thedegree of scattering may be altered to affect the energy deliverycharacteristics of the treatment device.

Other embodiments of dynamic scattering devices and methods are providedin U.S. patent application Ser. No. 12/176,310, filed Jul. 18, 2008,entitled “LIGHT DIFFUSING FIBER AND METHOD OF USE”, the entire contentsof which are hereby incorporated by reference.

In other embodiments, the energy delivering apparatus 1 may include ascattering or diffusing element. FIG. 2c illustrates an embodiment of anenergy delivering apparatus 1 which may include an element 3′ that maysubstantially scatter, diffuse and/or direct the energy from the energydelivery component 2. The element 3′ may, for example, include a solid,gel, semi-solid, emulsion, solution, liquid, suspension and/or any otherappropriate scattering, diffusing, energy directing and/or other energymodifying substance or combination thereof. The element 3′ may furtherbe coupled to the end of energy delivery component 2. In someembodiments, the element 3′ may include multiple regions ofsubstantially different properties, such as illustrated with the element3′ of FIG. 2d with first region 3 a′ and second region 3 b′. The energydelivery apparatus 1 may also include an energy directing element, suchas element 15 which may receive energy from energy delivery component 2in FIG. 2e . As illustrated, for example, a region 17 of the element 15may substantially block, reflect, redirect and/or otherwise preventenergy from exiting the element 15 on at least a portion of the element15. As illustrated, for example, the energy may then exit 19 through anenergy permeable portion 9.

Other exemplary embodiments of energy diffusing, scattering and/ormodifying elements are provided in U.S. Pat. No. 7,274,847, the entirecontents of which are hereby incorporated by reference.

In some embodiments, the temperature in the locality of the tissue fortreatment may be altered by altering the temperature of the circulatoryflow and/or surrounding tissue. Raising the temperature of the tissuemay also generally enhance the size of the ablated volume as a smallerincrease in temperature may be desired by energy delivery from thetreatment device, particularly at distances further away from thetreatment device. This may be accomplished through a variety of methods,which may include, but are not limited to, introducing temperaturecontrolled fluid into the circulatory flow, such as through a nearbyblood vessel, altering the temperature of the circulatory flow bycontact with a closed temperature controlled object, such as a closedcatheter, contacting the nearby tissue with a temperature controlledobject or material, such as a hot or cold pad, and/or any otherappropriate method. For example, a temperature controlled energydelivery device and/or heating element may be placed in a blood vesselwhich may be in proximity to and/or supply a tissue for treatment.

Also, the circulatory flow may be blocked and/or diverted from a tissuearea for treatment and a sterile, biocompatible temperature-controlledfluid may be introduced into the vasculature in place of the normalcirculatory fluid. In some embodiments, a fluid with more desirableoptical and/or thermal qualities than the normal circulatory fluid, suchas blood, may be utilized. For example, a fluid with lower absorptionand/or higher transmission of energy from a treatment device may beutilized to increase the amount of energy delivered to the target tissueand decrease the amount of energy absorbed by surrounding fluid. Thismay be useful and/or desirable in situations where there is a largequantity of circulatory fluid, such as, for example, in the liver, whereit is desirable to deliver as much energy as possible to the tissue fortreatment rather than energy being absorbed and/or diffused by thecirculatory fluid. This may also enable higher power energy sources tobe utilized with decreased effect on the surrounding tissues, especiallythrough energy absorption by the circulatory fluid.

In yet other embodiments, the treatment device may include materials ofhigh thermal conductivity. The treatment device may thus be temperaturecontrolled by application or removal of energy at a portion remote tothe target area, where the high thermal conductivity material may beutilized to appropriate distribute the temperature control along thetreatment device. The treatment device may also incorporate features forincreasing its thermal conductivity, such as, for example, heat transferelements which may include, for example, heat pipes and/or otherelements that enhance thermal conductivity.

In still other embodiments, the thermal therapy system 100 mayincorporate multiple treatment devices. The treatment devices may becontrolled as a group or they may be individually controlled. Thetreatment devices may be spatially oriented in or near a tissue fortreatment and may be utilized to affect treatment in a spatiallycontrolled manner, an example of which is illustrated in FIG. 3 withtreatment devices 120, 120′, 120″ and target 90. The treatment devices120, 120′, 120″ may, for example, be targeted in particular directionsfor coverage of a target 90. The treatment devices 120, 120′, 120″ mayalso be controlled in a temporal manner by controlling the activationand/or modulation of each device in a time-dependent manner. This may beuseful, for example, in controlling lesion formation by increasingenergy delivery in a given region of the treatment volume and/ordecreasing energy delivery in another region. This may aid in creatingmore uniform lesions, decreasing overall treatment time and in avoidingchar formation due to excess energy delivery. Multiple treatment devicesmay also be useful in controlling lesion shape. Any appropriate numberof treatment devices may be utilized.

In an exemplary embodiment, the multiple treatment devices may be laserprobes with fluid circulation and may be individually modulated by thecontrol system 130. The laser probes may, for example, be spatiallyoriented in or near a tissue for treatment to optimize and/or increasethe volume being treated. This may be used, for example, to increase theoverall size of a thermally generated lesion. Each laser probe may alsobe targeted such that energy delivery may be substantially confined to agiven volume. This may be accomplished with, for example, directionallaser probes which may deliver light energy in a particular generaldirection rather than, for example, diffusing energy in all directions.The fluid circulation characteristics of each laser probe may also beindividually modulated, as discussed above. The multiple probes may alsobe utilized to generate a base temperature profile or gradient in thetarget by circulating fluid of different temperatures through eachprobe.

In some embodiments, multiple treatment devices may be placed in or neara treatment by use of a guide. A guide, for example, may be utilized toaid in a substantially repeatable or more precise placement of eachtreatment device. FIG. 3a illustrates an example of a guide 300 whichmay be utilized with multiple treatment devices, such as treatmentdevices 120, 120′, 120″ as shown. The guide 300 may include, forexample, a plurality of holes 302 in the guide body 304, any of whichtreatment devices 120, 120′, 120″ may be inserted through such that eachtreatment device may be directed to a particular site in the target. Inan exemplary embodiment, the guide 300 may also include features foraiding in positioning and directing of treatment devices to the properlocation. For example, at least one fiducial marker may be utilized toaid in positing and/or orienting of the guide 300 and/or treatmentdevices, such as devices 120, 120′, 120″. A fiducial marker maygenerally be a feature, formation, device, portion of a device, and/orany other appropriate object or form that may be detectable by adetection device that may be in a substantially known and fixed spatialrelationship to another object or form, such as the guide 300. Also, atleast one fiducial marker may be utilized to resolve the position and/ororientation of the guide 300, such as, for example, by providing anappropriate number of reference points to form a plane which may have aknown and fixed spatial relationship with the guide 300. At least onefiducial marker may also include a form or shape that may have adetectable unique or semi-unique cross-section such that it may beindicative of position and orientation of an intersecting detectionplane of a detection device, such as an MRI slice. In general, detectionof a fiducial marker by a detection device, such as, for example, anMRI, CT and/or any other appropriate substantially computer-controlleddetection device, may utilize region growing methods to substantiallydetect the entire fiducial marker. In one embodiment, the guide 300 mayinclude fiducial markers 306, 308, 310, which may be utilized to resolvethe position and orientation of the guide 300 in space and/or to atarget volume using a detection device. A control system may utilize theknown dimensions of the guide 300 and the known positions of thefiducial markers 306, 308, 310, both in space and their fixed positionsrelative to the guide 300, to project the trajectory of the holes 302,such that treatment devices may be properly placed through selectedholes 302. This may include, for example, providing the insertion depthand insertion angle into the hole 302, if applicable. The control system130 may also calculate and prescribe a reorientation the guide 300 forbetter placement of treatment devices. In general, the fiducial markersmay be selected to appear on a given detection modality, such as, forexample, water under MRI or metallic objects under X-ray. A guide 300may also include features for enhancing the contrast of the holes 302such that they may be better detected by the detection device. This mayalso be useful for guiding treatment devices to the holes 302. Contrastenhancing agents for particular detection modalities may be utilized.The guide 300 may also include temperature controlled fiducial markerswhich may be resolved through temperature detection. This may be usefulas the detection device for a thermal therapy system 100 may generallyinclude detection for localizing temperature changes and/or absolutetemperatures within a detection volume.

An exemplary embodiment of a guide 300′ is illustrated in FIG. 3b ,which may be utilized with multiple treatment devices, such as treatmentdevices 120, 120′, 120″ as shown. The guide 300′ may include, forexample, a plurality of holes 302 in the guide body 304, any of whichtreatment devices 120, 120′, 120″ may be inserted through such that eachtreatment device may be directed to a particular site in the target, asillustrated in FIG. 3f . The guide 300′ may further include an extension309 which may be, for example, utilized for mounting and/or positioningthe guide 300′. The extension 309 may further be adjustable, such as,for example, adjustable for angle between it and the guide body 304. Theguide 300′ may further include at least one fiducial marker, such asfiducial markers 306, 308, 310. The markers may be integral to the guide300′ or they may also be separable. FIGS. 3c and 3d illustrate anexample of a separable fiducial marker 320, which may, for example, beany or all of the fiducial markers 306, 308, 310 of FIG. 3b . Thefiducial marker 320 may generally include a body 322 and a cavity 324.The cavity 324 may generally be filled with a material visible to adetection device, such as, for example, water for MRI, metal for X-ray,and/or any other material appropriate for a given detection device. Thecavity 324 may further be sealed and/or otherwise closed off tosubstantially retain a material. In one embodiment, as shown in thesee-through of FIG. 3d , the cavity 324 may include a central channel326 and may further include cross channels 328, 329. This may bedesirable as it may generally increase the detectable volume of thefiducial 320 and may also generate a substantially discrete point forpositioning reference, such as the intersection 330 of the channels 326,328, 329. In general, it may be desirable for the fiducial marker 320 tobe reusable and sterilizable.

In another embodiment, a guide 300″ may include at least one fiducialmarker that may substantially and independently define a plane. FIG. 3eillustrates an example of a guide 300″ with a body 304 and a pluralityof holes 302. The guide 300″ may further include a fiducial marker 340,which may substantially define a plane. For example, as illustrated, thefiducial marker 340 may include 2 linear segments 342, 343. It may begenerally appreciated that any appropriate geometric form and/orcombination of forms that may define a plane may be utilized.

In another aspect of the invention, the control system 130 of thethermal therapy system 100 may incorporate predictive and/or adaptivetreatment modulation. In one embodiment, the control system 130 maygenerate a predictive model of a treatment based on known and/or assumedparameters, and may calculate an appropriate treatment course, such as,for example, applying energy to a tissue at a particular rate and/orduration based on the predicted model. The control system 130 may thenmonitor the progress of treatment by receiving information from adetection device 110, and may then adapt to the measured progress of thetreatment by entering and/or altering parameters in the predicted modelto aid in generating a more accurate model, after which the controlsystem 130 may apply a modulation to the treatment, such as, forexample, an alteration to the energy delivery characteristics of atreatment device 120. In some embodiments, the control system 130 may,based on a model and available data, make a preemptive action ahead ofreceived data. This may be useful, for example, when utilizing adetection device 110 where there is a delayed receipt of data by thecontrol system 130. The control system 130 may, for example, determinethat a treatment should stop due to a predicted temperature over adesignated limit in the target. This may aid in minimizing damageoutside of the target due to data lag.

In yet another aspect of the invention, the thermal therapy system 100may incorporate safety systems. In one embodiment, the control system130 of a thermal therapy system 100 may shut down the treatment device120 and/or warn the user of a detected safety parameter. The controlsystem 130 may, for example, shut down the treatment device 120 inresponse to a detected temperature above a given level in theinformation provided by a detection device 110. This may be useful indetecting failures in a treatment device 120, such as, for example, alaser light transport medium breaking and/or otherwise overheating pasta design limitation. This may also be useful in detecting unintendedtemperature changes in the target, such as, for example, unintendedtemperature increases in a tissue area outside the target area. Othersafety features, such as, for example, temperature sensors, specificlight wavelength detectors and/or any other safety features may also beincorporated.

Referring to FIG. 4, a method 600 for utilizing real-time or nearreal-time feedback, and/or sequential detection to control an energydelivery system 100 is discussed according to one embodiment of thepresent invention. In step 602, detection device 110 may obtain data 111from measurements conducted on target 90 for use as initial referencedata for data processor 132. This initial reference data may be utilizedto develop an initial image representing, for example, magnitude,temperature, and/or damage. The initial reference data may also be usedto develop an initial reference temperature distribution inimplementations where detection device 110 may only capable of detectingtemperature differences, rather than absolute temperature, such as, forexample, MRI thermometry and/or other forms of temperature detection.

In step 604, the control system 130 may detect the positions and/ororientations of the treatment device(s) 120 in the data 111 to aid inproper placement and targeting of the treatment. The user may then enterand/or select treatment parameters, such as, for example, treatmentboundaries and threshold temperature at those boundaries, in step 606.The control system 130 may then calculate the energy deliveryrequirements for the treatment in step 608. This may include, but is notlimited to, selecting the amount of energy and/or energy profile fordelivery 608 a, the treatment duration 608 b, fluid circulationrate/rate profile 608 c and fluid temperature 608 d in a fluidcirculation treatment device, the orientation/position of the treatmentdevice 608 e, which may include the adjustment of a component within thetreatment device such as the translatable energy delivery componentdescribed above, scattering effects 608 f, such as, for example,circulating scattering material in the circulation fluid, theutilization and settings of multiple treatment devices 608 g, which mayinclude the detection of, projection through and/or reorientation of aguide, and/or any other appropriate parameters, such as the numerousexamples of adjustment and/or modulation provided above. The user mayalso manually input and/or alter the parameters determined by thecontrol system 130.

In general, the control system 130 may calculate, based on availableinformation, an optimized treatment plan which the user may accept oralter. An optimized treatment plan may in general maximize theirreversible damage to a target area while minimizing the damage toother areas. The optimization may also in general reduce and/or preventthe formation of charred tissue and/or otherwise undesirable treatmenteffects. Such automatic optimization tuning may be desirable as a giventhermal therapy system 100 may incorporate multiple parameters which mayexceed the level of easy and/or expedient consideration by a user andmay take full advantage of the processing and calculation abilities ofan assisted control system, such as by a computerized system. Automaticoptimization tuning may thus take advantage of changeablecharacteristics in the thermal therapy system rather than attempting tooptimize a treatment while working around otherwise unalteredcharacteristics of the system. The automatic optimization may alsobecome increasingly more useful as more devices and tools becomeavailable with controllable parameters and/or settings. Also, the usermay also apply limitations on any of the available parameters and/orsettings for further control of the optimization scheme. For example, auser may apply a time limitation for the treatment plan to accommodate apatient and/or limitations on the usage of equipment. It may beappreciated that a wide array of situations and/or conditions may beaccommodated for through use of a highly adjustable, automaticoptimization for a treatment, which may aid in streamlining the overalltreatment experience.

After generating an optimized treatment plan, the system may thenproceed to apply energy for the treatment in step 610. This may includeactivating and modulating the energy source of a treatment device 120,such as a laser, as well as activating and modulating the other elementsof the system, such as a circulation media supply apparatus. The controlsystem 130 may then monitor the progress of the treatment in step 612through data from the detection device 110, which may be operating inreal-time and/or near real-time (e.g. a new dataset every few seconds),or in a sequential detection manner, such as prior to energy deliveryand immediately after energy delivery. The control system 130 may alsodetect and/or compensate for motion in the target, such as, for example,by controlling the detection device to correct for motion in the targetand/or processing the data from the detection device to account formotion correction. If during monitoring the control system 130 detects asafety concern, it may automatically proceed to a STOP command 620,which may halt the delivery of energy to the target, and it may alertthe user of the concern. The user may also utilize the STOP command 620at any time. The control system 130 may also utilize an externaltemperature monitor as a control. For example, a separate temperaturemonitor, such as a thermometer or other temperature sensor, may beplaced within the detection space of the detection device 110. Thecontrol system 130 may then compare the temperature measured by theexternal temperature monitor with the temperature determined from thedetection device 110. This may be utilized to correct for temperatureerrors, such as, for example, with temperature detection devices thatonly measure relative temperature changes rather than absolutetemperature.

The control system 130 may continuously process data received from thedetection device to recalculate the requirements of the treatment instep 614. If the treatment is determined to be incomplete, e.g. theboundaries selected in the target have not reached a given temperature,the control system 130 may alter the energy delivery characteristics ofthe treatment using the data feedback and/or sequential detection fromthe detection device 110 at step 616. The control system 130 may alsodetermine that no alterations are necessary. The system may then applyenergy to the target at step 610 utilizing the new or unchangedparameters. This cycle may continue until the treatment is determined tobe complete or manually halted, after which it may proceed to the STOPcommand 620.

Example of Acquiring Data from a Detection Device 1

For example, in communicating with a GE scanner running the LX operatingsystem, a method for acquiring data from the device may include:

1) connecting to the scanner using an FTP connection protocol;

2) listing all or some of the files found in the/export/home1/sdc_image_pool/mri_scan directory (or other equivalentdirectory or link thereto);

3) sorting the all or some of the returned file names to determine thelargest first number in any of the file names;

4) determining a first filename;

5) checking the size and/or execute status of the file permission for afile with the first determined filename;

6) requesting retrieval of the first file with the first determined filename as soon as the execute permission has been set positively and/orthe file size indicates the file is complete;

7) receiving the first file with the first determined filename;

8) determining a next filename; and

9) performing steps 5-8 above repeatedly for as long as is desirable.

Example of Acquiring Data from a Detection Device 2

For example, in communicating with a GE scanner running the EXCITEoperating system, a method for acquiring data from the device mayinclude:

1) connecting to the scanner using an FTP connection protocol;

2) listing all or some of the files or directories found in the/export/home1/sdc_image_pool/images directory (or equivalent directoryor link thereto);

3) sorting the all or some of the returned file or directory names todetermine a most recent directory name;

4) determining a first filename and determined directory location;

5) checking the existence of the first determined filename in thedetermined directory location;

6) requesting retrieval of the first file with the first determined filename as soon as it exists;

7) receiving the first file with the first determined filename;

8) determining a next filename; and

9) performing steps 5-8 above repeatedly for as long as is desirable.

Example of Acquiring Data from a Detection Device 3

For example, in communicating with a Siemens scanner running the Syngoapplication within the Windows.RTM. operating system, a method foracquiring data from the device may include:

1) connecting to the scanner using an FTP or SMB connection protocol;

2) obtaining a listing of all directory names within a given directory;

3) determining a most recent directory based on most recent file accessor modification time-stamp;

4) obtaining a listing of all files in the determined most recentdirectory and comparing that listing to a listing of files which havealready been retrieved onto the local machine;

5) determining the names of files which exist on the scanner but whichhave not yet been retrieved onto the local machine;

6) determining the order in which the files should be retrieved based onexamination of the determined file names;

7) retrieving those files using an FTP or SMB protocol networkconnection;

8) waiting a specified amount of time; and

9) performing steps 4-8 above repeatedly for as long as is desirable.

Example of Acquiring Data from a Detection Device 4

For example, in communicating with a Siemens scanner running the Syngoapplication within the Windows.RTM. operating system, a method foracquiring data from the device may include:

1) connecting to the scanner using an FTP or SMB connection protocol;

2) determining a target directory on the scanner filesystem;

3) determining the current clock date and time on the scanner system;

4) determining a filename component based on the determined date andtime;

5) obtaining a listing of all files in the determined target directoryconforming to or containing the determined filename component;

6) determining the order in which the listed files (if any) should beretrieved based on examination of the filenames obtained via thelisting;

7) retrieving those files using an FTP or SMB protocol networkconnection;

8) waiting a specified amount of time; and

9) performing steps 4-8 above repeatedly for as long as is desirable.

It will be appreciated by those of ordinary skill in the art that thepresent invention can be embodied in other specific forms withoutdeparting from the spirit or essential character hereof. The presentdescription is therefore considered in all respects to be illustrativeand not restrictive. The scope of the present invention is indicated bythe appended claims, and all changes that come within the meaning andrange of equivalents thereof are intended to be embraced therein.

What is claimed is:
 1. A method for thermal therapy, comprising: a)receiving spatially resolvable temperature sensitive data from at leastone detection device at a control system, said detection deviceinterrogating a target with radiation to generate said data; b)determining at least one energy delivery characteristic of at least onetreatment device based at least in part on said data using said controlsystem; c) modulating said at least one treatment device using at leastsaid energy delivery characteristic; and repeating steps a-c tosubstantially affect a preselected characteristic of said target; d)guiding the at least one treatment device to the target with a guidehaving at least one first fiducial marker for identifying a position andorientation of the guide; and e) adjusting an extension member extendingfrom the guide to vary an angle between the extension plate member andthe guide, wherein the extension member includes at least one secondfiducial marker attached thereto.
 2. The method of claim 1, furthercomprising utilizing a predictive model of the preselectedcharacteristic response of the target for delivering energy at leastpartially based on said model.
 3. The method of claim 2, furthercomprising modifying said predictive model using said data from saiddetection device during said therapy.
 4. The method of claim 1, furthercomprising: determining at least one energy delivery characteristic of aplurality of treatment devices; and independently modulating each of thetreatment devices using the at least one energy delivery characteristic.5. The method of claim 1, further comprising detecting the position andorientation of the at least one treatment device relative to the target.6. The method of claim 1, wherein the at least one energy deliverycharacteristic includes at least one of an amount of energy, an energyprofile for delivery, a treatment duration, a fluid circulation rateprofile, a fluid temperature, and an orientation and position of the atleast one treatment device.
 7. The method of claim 4, further comprisingguiding the plurality of treatment devices to the target with the guidehaving the at least one first fiducial marker for identifying theposition and orientation of the guide.
 8. The method of claim 7, furthercomprising adjusting the extension member extending from the guide tovary an angle between the extension member and the guide, wherein theextension member includes the at least one second fiducial markerattached thereto.